Z-0656-2019Class II

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

Name: Z-0656-2019 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Creator: Covidien Llc
Published: 2018-11-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-11-05 / Terminated

FDA source

COVIDIEN LLC began a recall of 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826 on 2018-11-05. FDA classified it as Class II and gives the reason as "The product was released into commercial distribution while subject to importation refusal". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0656-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-05
Posted: 2018-12-21
Terminated: 2020-08-14
Recalling firm: Medtronic, Inc.
Product: 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: The product was released into commercial distribution while subject to importation refusal.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall letters dated 11/5/18 were sent to customers.
Quantity in commerce: 32,071 units
Distribution: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Product codes and lots: Lot Number 1816211264

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0656-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0656-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20

Product code GCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)